Metastatic Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 2X-121
Product Code: 2X-121
Pharmaceutical Form: Capsule
INN or Proposed INN: 2X-121
CAS Number: 1140964-99-3
Current Sponsor code: 2X-121
Other descriptive name: 2X-121
Concentration un
Sponsors
Oncology Venture Aps
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form. 2. Age 18 years or older. 3. Histologically or cytological documented mBC (independent of hormone receptor, HER2 status and BRCA1 or 2 status) relapsed on 2 or more different prior therapies. 4. Measurable disease by CT scan or MRI. 5. With a drug response prediction (DRP®) for 2X-121 with an outcome measured as being in the upper 10% likelihood of response. 6. Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed. 7. Performance status of ECOG = 1. 8. Recovered to Grade 4.6 mmol/L c. Platelets = 100 x 109 /L d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN* e. Serum bilirubin = 1.5 ULN f. Alkaline phosphatase = 3 x ULN* g. Creatinine = 1.5 ULN h. Blood urea within normal limits 12. Life expectancy equal or longer than 3 months. 13. Sexually active females of child-producing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period. 2. Previous treatment with PARP inhibitors. 3. Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study. 4. Any active infection requiring parenteral or oral antibiotic treatment. 5. Known HIV positivity. 6. Known active hepatitis B or C. 7. Clinical significant (i.e. active) cardiovascular disease: a. Stroke within = 6 months prior to day 1 b. Transient ischemic attach (TIA) within = 6 months prior to day 1 c. Myocardial infarction within = 6 months prior to day 1 d. Unstable angina e. New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF) f. Serious cardiac arrhythmia requiring medication 8. Other medications or conditions, including surgery, that in the Investigator’s opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results. 9. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121. 10. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy. 11. Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the anti-tumour efficacy after treatment with 600 mg 2X-121 as single agent in a 21-days cycle in metastatic breast cancer patients selected by the 2X-121 DRP.;Secondary Objective: - To evaluate progression free survival (PFS) after administration of 2X-121 in patients with mBC. · To evaluate duration of objective response after administration of 2X-121 in patients with mBC. · To evaluate overall survival (OS) after administration of 2X-121 in patients with mBC. · To evaluate the safety profile of 2X-121 in patients with mBC. · To further establish the clinical validation of the use of the 2X-121 DRP® in selection of patients with mBC treated patient;Primary end point(s): The primary endpoint is clinical benefit rate (CBR) defined as complete response (CR), partial response (PR) or stable disease (SD) > 24 weeks using the RECIST criteria version 1.1. ;Timepoint(s) of evaluation of this end point: · All patients who received at least 2 treatment cycles will be considered evaluable for response. · Patients discontinuing early due to disease progression will also be evaluable for response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · Progression free survival · Duration of response (from first response to progression). · Overall survival.;Timepoint(s) of evaluation of this end point: · All patients who received at least 2 treatment cycles will be considered evaluable for response. · Patients discontinuing early due to disease progression will also be evaluable for response. - All patiients having received atleast one dosage of IMP will be evaluable for safety | — |
Countries
Denmark
Contacts
Public ContactMalgorzata Tuxen
Herlev og Gentofte Hospital
Outcome results
None listed